During surgery a patient usually is placed under anesthesia and the most common delivery system consists of canisters containing anesthesia gases and oxygen, a system of regulating gas flow and the patient's breathing, and a device ensuring the potency of the patient's airway for breathing, oxygenation and the delivery of an anesthetic gas mixture. A mask is used to provide oxygen to the patient either before the patient is anesthetized, while the patient is anesthetized, or if the patient is sedated during the surgery or procedure. However, one of the drawbacks of mask ventilation is that it requires constant contact between the provider's hands and the patient's face to hold the mask in place and keep the patient in the sniffing position in order to ensure that oxygen and anesthetic gases do not leak out into the air and that the patient's airway remains patent. If the provider does not maintain the patient in the sniffing position, a dangerous complication known as upper airway obstruction may occur. The reason the provider needs to perform continuous mask holding and maneuvering is due to the human anatomy and physiology. When muscles of the jaw, tongue and upper airway relax due to sedatives and/or muscle relaxants given to the patient for sedation and/or anesthesia, wherein, the jaw of the patient drops and the tongue obstructs the airway resulting in snoring (partial obstruction) or apnea (complete inability for oxygen to pass via the upper airway into the lungs), the upper airway (mouth, pharynx, larynx) may become partially obstructed and possibly completely closed. Another problem exists when a provider fails to administer enough anesthesia or sedative or the anesthesia or sedative begins to wear off and the patient begins to move. This can cause the patient's airway to obstruct as well since the patient's head and neck position are no longer in the sniffing position. Patient movement during surgery also can be dangerous because it can cause the surgeon to make a mistake, particularly in eye, ear, nose, neck, head, and throat surgery.
Notwithstanding the aforesaid potential problems, the use of facemasks, whether nasal masks, which only cover the nose, or facemasks, which cover both the nose and mouth, to apply inhalational agents, such as oxygen or volatile anesthetic gases, is essentially universal in the medical field. However, up until now, nasal masks and facemasks have been used separately as either nasal masks alone or facemasks alone. A significant clinical need has emerged, where combining a nasal mask with a mouth mask into one could have a substantial impact on patient safety during both endotracheal intubation and monitored anesthesia care cases involving sedation. For example, current standard of care recommends pre-oxygenating (delivering 100% oxygen via facemask) a patient for several minutes prior to endotracheal intubation in order to fill the patient's lungs with oxygen. Also, pre-oxygenating a patient significantly lengthens the time (2-8 minutes) that patient begins to desaturate (blood-oxygen levels begin to fall to critically low levels). Exemplary of gas inhalation masks used in administering general anesthesia (GA) to a patient is that disclosed in U.S. Pat. No. 5,975,079 (Hellings et al). As indicated by this patent, an acceptable anesthesia mask should be disposable, made of transparent material, have a strap or straps to hold the mask in place, when desired, be of sufficient size to cover the patient's nose and mouth, and have a pneumatic sealing cushion, not only to promote patient comfort, but to prevent exposing the medical staff to anesthesia or other applied gas or gases. See also U.S. Pat. No. 8,336,549 B2 in which there is discussed a disposable anesthesia face mask comprising a shell member having an annular flange and a donut shaped pneumatic sealing cushion attached to the shell member annular flange. The shell member and its flange are “pear-shaped” defining a nasal portion of first transverse extent, a mouth portion of second transverse extent, and an under-the-chin engagement portion of third transverse extent, where the second transverse extent is greater than the first transverse extent and the third transverse extent is greater than the second transverse extent.
Other prior art anesthesia masks and CPAP masks are described in U.S. Pat. No. 5,738,094; US 2014/0083425; US 2003/0024533; U.S. Pat. No. 6,779,524; US 2014/0076311; U.S. Pat. Nos. 8,001,968, 6,112,746; 8,528,558; 7,178,524; 7,036,508; 5,560,354; US 2015/0059759; and U.S. Pat. No. 5,243,971
Furthermore, mask straps and harnesses are commonly used to hold masks on a patient. However, a common problem in the majority of cases today with the use of currently available mask straps and/or the head harness is that they still require the provider to hold and maneuver the mask continuously during the surgery because there is no way of fixing patient's head and neck to a surface. U.S. Pat. No. 6,981,503 B1 (hands-free anesthesia mask) proposes a way of attaching a head strap to the face; however, it does not provide a means of restricting head and neck movement. Many times when the patient is relaxed with sedation and anesthesia the head falls forward, causing collapse of the airway. One way to solve this problem is to fix the patients face mask or head to a base surface which will prevent it from falling forward. Also, to avoid partial and/or complete obstruction the provider can perform a maneuver called the “jaw thrust” maneuver. The “jaw thrust” maneuver” is done with one hand moving the jaw up and forward to move the tongue so that the airway is opened. The “jaw thrust” is performed while holding a mask over the patient's mouth and nose to deliver oxygen. In order to ventilate the patient while performing a “jaw thrust” the provider is required to hold the mask over the patient's face almost constantly and prevents the ability to perform other tasks during the surgery. This has led to a significant loss of popularity of the mask anesthetics and the increased use of other airway devices, which are more invasive and have greater potential side effects and complications. Also, a problem exists that when a mask is adjusted on a patient when in a sniff position, when the patient's head is moved to a more natural or “vertical” position, e.g., post operation, the mask becomes loose on the patient's head. See also U.S. Pat. Nos. 6,439,231; 6,003,511; 5,983,896; 5,778,872; 4,265,235; 5,404,873; 3,856,051; 3,556,097; 4,007,737; 4,188,946; 4,265,235; 4,463,755; 4,232,667; 4,596,246; 5,121,746; 5,284,160; 5,778,872; and U.S. Pat. No. 6,129,082; U.S. 2003/0183232 A1; U.S. Pat. Nos. 3,815,596; 5,462,050; 6,035,852; 6,412,488; 6,736,139; 6,792,943; 6,981,503; 7,753,051 6,981,503 B1; 7,753,051; U.S. 2009/0178680; U.S. Pat. Nos. 4,905,712; 3,889,668; 3,897,777; US 2007/0295335.
In our co-pending PCT Application Serial No. PCT/US14/44934, we provide an improved mask strap system for an anesthesia mask that allows hands-free patient ventilation while maintaining the patient in the sniffing position and preventing head and neck movement. We also provide an anesthesia strap system for maintaining an anesthesia face mask on the head of the user, that prevents movement of the patient's head and neck, and can be placed in front of the patient's face. Therefore if the patient is already lying down, sedated, or anesthetized, the provider will not have to lift the patient's head off the table. We also provide an anesthesia mask anchor ring system including a plurality of elastomeric cords connecting the mask anchoring to a support.